A Consumer Reports investigation has found that medical devices like defibrillators or joint replacements may not be clinically tested at all.
Dr. Stephen Tower is an orthopedic surgeon. When the arthritis in his hip became too hard to bear, he opted for a metal-on-metal hip. But the new hip, he says, caused him so much pain, exhaustion, and depression that he had to have it removed.
"The tissues around the hip had been destroyed and that metal debris was spreading down my thigh," he said.
Dr. Tower says normal friction in the artificial joint caused cobalt, a toxic metal, to be released into his body, leading to serious tissue, heart, brain, and thyroid problems
"This particular type of hip was called the ASR XL. It was made of chrome cobalt metal, but it was never clinically tested before the FDA cleared it to be sold," said Nancy Metcalf with Consumer Reports. "Because of high failure rates and complications like Dr. Tower experienced, it's now off the market."
While metal-on-metal hips have been widely criticized, a Consumer Reports' investigation has found there are other dangerous devices that are being implanted.
"Hundreds of thousands of women have had mesh slings inserted to support internal organs as they age, like the uterus and bladder," Metcalf said. "Again, these products were never clinically tested before being marketed for this use."
The FDA's own database shows thousands of complaints about the mesh, including debilitating infections. Yet it's still on the market -- not even classified as high-risk.
"We strongly believe that the FDA should require rigorous testing for implantable devices just like they do for prescription drugs now," Metcalf said.
Fortunately for Dr. Tower, after his metal hip was replaced with a plastic and ceramic one, he was eventually able to return to his favorite athletic activities.
Consumer Reports says creating a national registry is essential to keeping track of implanted medical devices and to alert patients if there is a problem. Currently there is no such tracking in the US.